Browse Drug Recalls
942 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 942 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 942 FDA drug recalls in TX.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 16, 2026 | UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syrin... | Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrect... | Class I | McKesson |
| Jan 6, 2026 | AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each | cGMP deviations. | Class II | Encon Safety Products Co |
| Dec 17, 2025 | BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and I... | Lack of Assurance of Sterlity | Class II | CareFusion 213, LLC |
| Dec 15, 2025 | MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7 | Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafi... | Class I | StuffbyNainax |
| Oct 29, 2025 | POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly con... | Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the produc... | Class I | Otsuka ICU Medical LLC |
| Oct 29, 2025 | POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly co... | Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the produc... | Class I | Otsuka ICU Medical LLC |
| Oct 27, 2025 | 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake... | Lack of Assurance of Sterility: Potential for flexible container leaks. | Class II | Otsuka ICU Medical LLC |
| Oct 14, 2025 | Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY,... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSE... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FO... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, ... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUB... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSER... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERIL... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, Fa... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STER... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERIL... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY,... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, Fa... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBC... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 10, 2025 | R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Trometha... | Presence of Particulate Matter | Class II | QuVa Pharma, Inc. |
| May 15, 2025 | BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of... | Class II | CareFusion 213, LLC |
| May 2, 2025 | Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Mult... | Lack of Assurance of Sterility | Class II | Empower Clinic Services, LLC dba Empower Pharmacy |
| Mar 31, 2025 | Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38... | CGMP Deviations | Class II | Medisca Inc. |
| Mar 11, 2025 | Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/A... | Chemical contamination: presence of benzene | Class II | Fruit Of The Earth, Inc. |
| Mar 11, 2025 | CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (... | Chemical contamination: presence of benzene | Class II | Fruit Of The Earth, Inc. |
| Mar 6, 2025 | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/10... | Lack of Assurance of Sterility | Class II | QuVa Pharma, Inc. |
| Mar 6, 2025 | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/10... | Lack of Assurance of Sterility | Class II | QuVa Pharma, Inc. |
| Mar 6, 2025 | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/... | Lack of Assurance of Sterility | Class II | QuVa Pharma, Inc. |
| Feb 14, 2025 | BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and... | Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. | Class I | CareFusion 213, LLC |
| Jan 17, 2025 | Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL... | cGMP Deviations: Product intended for quarantine was inadvertently distributed. | Class II | McKesson |
| Dec 18, 2024 | Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufa... | Non-Sterility | Class I | Alcon Research LLC |
| Nov 14, 2024 | UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323 | cGMP Deviations: the firm initiated a recall after notification from the distributor that product... | Class II | MXBBB |
| Sep 5, 2024 | Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose... | Lack of Assurance of Sterility | Class II | Empower Pharmacy |
| Aug 2, 2024 | Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multipl... | Lack of Assurance of Sterility | Class II | EMPOWER CLINIC SERVICES LLC |
| Jun 26, 2024 | Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystallin... | CGMP Deviations and Presence of Particulate Matter: Glass | Class II | Medisca Inc. |
| May 1, 2024 | CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Fl... | Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria | Class II | Pharma Nobis LLC |
| May 1, 2024 | Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free G... | Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria | Class II | Pharma Nobis LLC |
| Apr 20, 2024 | Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, Thi... | Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate | Class I | Revive Rx LLC dba Revive Rx Pharmacy |
| Apr 17, 2024 | Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor ... | Out of Specification for active ingredient | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octy... | Out of Specification for active ingredient | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octy... | Out of Specification for active ingredient | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched ... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched ... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched ... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.